Implantable adjunct systems for determining adjunct skew

ABSTRACT

An implantable adjunct for use with a surgical stapling instrument is provided. The implantable adjunct comprises means for allowing a clinician to determine the degree of skew, if any, that the adjunct may experience when implanted into a subject with a surgical stapling instrument. The implantable adjunct comprises one or more reference systems configured to be compared to the staples, the edges of the adjunct, and/or any other adjunct elements by a clinician once the adjunct has been implanted into the subject. The one or more reference systems comprise references that define one or more zones of the adjunct. A clinician can visually determine what zone, or zones, of the adjunct the staples have satisfactorily, and/or unsatisfactorily, purchased the adjunct.

BACKGROUND

Currently, there are several methods utilized for holding an implantableadjunct on a staple cartridge and/or an anvil of a surgical staplinginstrument before the surgical stapling instrument is fired. However,after the surgical stapling instrument is fired and the implantableadjunct is implanted against the tissue by a plurality of staples, theclinician may or may not be able to determine whether the implantableadjunct became misaligned, or skew, with respect to the staple cartridgeduring manipulation, positioning, and/or firing of the instrument.Presently, the clinician simply looks at the implanted adjunct toestimate whether the adjunct was properly captured by the staples ornot. As such, there is a need for being able to clearly determine if theadjunct was properly captured by the staples. The foregoing discussionis intended only to illustrate various aspects of the related art in thefield of the invention at the time, and should not be taken as adisavowal of claim scope.

SUMMARY

The present invention is directed toward an implantable adjunct for usewith a surgical stapling instrument. The implantable adjunct is intendedto be implanted into a subject using a surgical stapling instrument. Aplurality of staples are configured to be fired from the surgicalinstrument to fasten tissue and implant the adjunct. The adjunctcomprises a reference system for visually amplifying the position of thestaples relative to the implantable adjunct once the staples have beenfired. The foregoing discussion is intended only to illustrate certainaspects of the invention, and should not be taken as a disavowal ofclaim scope.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of the embodiments described herein are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation, together withadvantages thereof, may be understood in accordance with the followingdescription taken in conjunction with the accompanying drawings asfollows:

FIG. 1 is a perspective view of an end effector system in accordancewith at least one embodiment comprising a first jaw, a second jaw, andan implantable adjunct comprising a first reference system;

FIG. 2 is a perspective view of the implantable adjunct and the firstreference system of FIG. 1;

FIG. 3 is a cross-sectional view of the first jaw, the implantableadjunct, and the first reference system of FIG. 1;

FIG. 4 is a top view of the implantable adjunct and the first referencesystem of FIG. 1, wherein the tissue and the adjunct are purchased by aplurality of staples according to a first scenario;

FIG. 5 is a top view of the implantable adjunct and the first referencesystem of FIG. 1, wherein the tissue and the adjunct are purchased by aplurality of staples according to a second scenario;

FIG. 6 is a top view of an implantable adjunct comprising a secondreference system in accordance with at least one embodiment;

FIG. 7 is a perspective view of an implantable adjunct comprising athird reference system in accordance with at least one embodiment;

FIG. 8 is a cross-sectional side view of the implantable adjunct of FIG.7 positioned on the first jaw of FIG. 1;

FIG. 9 is a top view of the implantable adjunct of FIG. 7, wherein thetissue and the adjunct are purchased by a plurality of staples accordingto a first scenario;

FIG. 10 is a top view of the implantable adjunct of FIG. 7, wherein thetissue and the adjunct are purchased by a plurality of staples accordingto a second scenario;

FIG. 11 is a top view of the implantable adjunct of FIG. 7 and a partialoutline of the end effector system of FIG. 1 before the implantableadjunct is implanted;

FIG. 11A-11C are top views of the implantable adjunct of FIG. 7illustrating multiple implantation scenarios;

FIG. 12 is a top view of an implantable adjunct in accordance with atleast one embodiment comprising a first woven reference system;

FIG. 13 is a top view of an implantable adjunct in accordance with atleast one embodiment comprising a second woven reference system; and

FIG. 14 is a top view of an implantable adjunct in accordance with atleast one embodiment.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate various embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

The Applicant of the present application also owns the U.S. patentapplications identified below which are each herein incorporated byreference in their respective entireties:

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U.S. patent application Ser. No. 12/894,377, entitled SELECTIVELYORIENTABLE IMPLANTABLE FASTENER CARTRIDGE; now U.S. Pat. No. 8,393,514;

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U.S. patent application Ser. No. 12/894,389, entitled COMPRESSIBLEFASTENER CARTRIDGE; now U.S. Pat. No. 8,740,037;

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U.S. patent application Ser. No. 13/241,637, entitled SURGICALINSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATIONMOTIONS; now U.S. Pat. No. 8,789,741;

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U.S. patent application Ser. No. 13/433,103, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING A PLURALITY OF LAYERS; now U.S. PatentApplication Publication No. 2012/0241498;

U.S. patent application Ser. No. 13/433,098, entitled EXPANDABLE TISSUETHICKNESS COMPENSATOR; now U.S. Patent Application Publication No.2012/0241491;

U.S. patent application Ser. No. 13/433,102, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING A RESERVOIR; now U.S. Patent ApplicationPublication No. 2012/0241497;

U.S. patent application Ser. No. 13/433,114, entitled RETAINER ASSEMBLYINCLUDING A TISSUE THICKNESS COMPENSATOR; now U.S. Patent ApplicationPublication No. 2012/0241499;

U.S. patent application Ser. No. 13/433,136, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING AT LEAST ONE MEDICAMENT; now U.S. PatentApplication Publication No. 2012/0241492;

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U.S. patent application Ser. No. 13/433,144, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD; now U.S.Patent Application Publication No. 2012/0241500;

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U.S. patent application Ser. No. 13/763,094, entitled LAYER COMPRISINGDEPLOYABLE ATTACHMENT MEMBERS; now U.S. Patent Application PublicationNo. 2013/0256377;

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U.S. patent application Ser. No. 13/433,147, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING CHANNELS; now U.S. Patent Application PublicationNo. 2013/0256369;

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U.S. patent application Ser. No. 13/763,035, entitled ACTUATOR FORRELEASING A TISSUE THICKNESS COMPENSATOR FROM A FASTENER CARTRIDGE; nowU.S. Patent Application Publication No. 2013/0214030;

U.S. patent application Ser. No. 13/763,042, entitled RELEASABLE TISSUETHICKNESS COMPENSATOR AND FASTENER CARTRIDGE HAVING THE SAME; now U.S.Patent Application Publication No. 2013/0221063;

U.S. patent application Ser. No. 13/763,048, entitled FASTENER CARTRIDGECOMPRISING A RELEASABLE TISSUE THICKNESS COMPENSATOR; now U.S. PatentApplication Publication No. 2013/0221064;

U.S. patent application Ser. No. 13/763,054, entitled FASTENER CARTRIDGECOMPRISING A CUTTING MEMBER FOR RELEASING A TISSUE THICKNESSCOMPENSATOR; now U.S. Patent Application Publication No. 2014/0097227;

U.S. patent application Ser. No. 13/763,065, entitled FASTENER CARTRIDGECOMPRISING A RELEASABLY ATTACHED TISSUE THICKNESS COMPENSATOR; now U.S.Patent Application Publication No. 2013/0221065;

U.S. patent application Ser. No. 13/763,021, entitled STAPLE CARTRIDGECOMPRISING A RELEASABLE COVER; now U.S. Patent Application PublicationNo. 2014/0224686;

U.S. patent application Ser. No. 13/763,078, entitled ANVIL LAYERATTACHED TO A PROXIMAL END OF AN END EFFECTOR; now U.S. PatentApplication Publication No. 2013/0256383;

U.S. patent application Ser. No. 13/763,095, entitled LAYER ARRANGEMENTSFOR SURGICAL STAPLE CARTRIDGES; now U.S. Patent Application PublicationNo. 2013/0161374;

U.S. patent application Ser. No. 13/763,147, entitled IMPLANTABLEARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES; now U.S. Patent ApplicationPublication No. 2013/0153636;

U.S. patent application Ser. No. 13/763,192, entitled MULTIPLE THICKNESSIMPLANTABLE LAYERS FOR SURGICAL STAPLING DEVICES; now U.S. PatentApplication Publication No. 2013/0146642;

U.S. patent application Ser. No. 13/763,161, entitled RELEASABLE LAYEROF MATERIAL AND SURGICAL END EFFECTOR HAVING THE SAME; now U.S. PatentApplication Publication No. 2013/0153641;

U.S. patent application Ser. No. 13/763,177, entitled ACTUATOR FORRELEASING A LAYER OF MATERIAL FROM A SURGICAL END EFFECTOR; now U.S.Patent Application Publication No. 2013/0146641;

U.S. patent application Ser. No. 13/763,037, entitled STAPLE CARTRIDGECOMPRISING A COMPRESSIBLE PORTION; now U.S. Patent ApplicationPublication No. 2014/0224857;

U.S. patent application Ser. No. 13/433,126, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING TISSUE INGROWTH FEATURES; now U.S. PatentApplication Publication No. 2013/0256366;

U.S. patent application Ser. No. 13/433,132, entitled DEVICES ANDMETHODS FOR ATTACHING TISSUE THICKNESS COMPENSATING MATERIALS TOSURGICAL STAPLING INSTRUMENTS; now U.S. Patent Application PublicationNo. 2013/0256373;

U.S. patent application Ser. No. 13/851,703, entitled FASTENER CARTRIDGECOMPRISING A TISSUE THICKNESS COMPENSATOR INCLUDING OPENINGS THEREIN;now U.S. Patent Application Publication No. 2014/0291382;

U.S. patent application Ser. No. 13/851,676, entitled TISSUE THICKNESSCOMPENSATOR COMPRISING A CUTTING MEMBER PATH; now U.S. PatentApplication Publication No. 2014/0291379;

U.S. patent application Ser. No. 13/851,693, entitled FASTENER CARTRIDGEASSEMBLIES; now U.S. Patent Application Publication No. 2014/0291381;

U.S. patent application Ser. No. 13/851,684, entitled FASTENER CARTRIDGECOMPRISING A TISSUE THICKNESS COMPENSATOR AND A GAP SETTING ELEMENT; nowU.S. Patent Application Publication No. 2014/0291380;

U.S. patent application Ser. No. 14/187,387, entitled STAPLE CARTRIDGEINCLUDING A BARBED STAPLE, now U.S. Patent Application Publication No.2014/0166724;

U.S. patent application Ser. No. 14/187,395, entitled STAPLE CARTRIDGEINCLUDING A BARBED STAPLE, now U.S. Patent Application Publication No.2014/0166725;

U.S. patent application Ser. No. 14/187,400, entitled STAPLE CARTRIDGEINCLUDING A BARBED STAPLE, now U.S. Patent Application Publication No.2014/0166726;

U.S. patent application Ser. No. 14/187,383, entitled IMPLANTABLE LAYERSAND METHODS FOR ALTERING IMPLANTABLE LAYERS FOR USE WITH SURGICALFASTENING INSTRUMENTS, now U.S. Patent Application Publication No.2015/0238185;

U.S. patent application Ser. No. 14/187,386, entitled IMPLANTABLE LAYERSAND METHODS FOR ALTERING ONE OR MORE PROPERTIES OF IMPLANTABLE LAYERSFOR USE WITH FASTENING INSTRUMENTS, now U.S. Patent ApplicationPublication No. 2015/0239180;

U.S. patent application Ser. No. 14/187,390, entitled IMPLANTABLE LAYERSAND METHODS FOR MODIFYING THE SHAPE OF THE IMPLANTABLE LAYERS FOR USEWITH A SURGICAL FASTENING INSTRUMENT, now U.S. Patent ApplicationPublication No. 2015/0238188;

U.S. patent application Ser. No. 14/187,389, entitled IMPLANTABLE LAYERASSEMBLIES, now U.S. Patent Application Publication No. 2015/0238187;

U.S. patent application Ser. No. 14/187,385, entitled IMPLANTABLE LAYERSCOMPRISING A PRESSED REGION, now U.S. Patent Application Publication No.2015/0238191;

U.S. patent application Ser. No. 14/187,384, entitled FASTENING SYSTEMCOMPRISING A FIRING MEMBER LOCKOUT, now U.S. Patent ApplicationPublication No. 2015/0238186;

U.S. patent application Ser. No. 14/827,856, entitled IMPLANTABLE LAYERSFOR A SURGICAL INSTRUMENT;

U.S. patent application Ser. No. 14/827,907, entitled IMPLANTABLE LAYERSFOR A SURGICAL INSTRUMENT; and

U.S. patent application Ser. No. 14/827,932, entitled IMPLANTABLE LAYERSFOR A SURGICAL INSTRUMENT.

Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. It will be understood by those skilled in theart, however, that the embodiments may be practiced without suchspecific details. In other instances, well-known operations, components,and elements have not been described in detail so as not to obscure theembodiments described in the specification. Those of ordinary skill inthe art will understand that the embodiments described and illustratedherein are non-limiting examples, and thus it can be appreciated thatthe specific structural and functional details disclosed herein may berepresentative and illustrative. Variations and changes thereto may bemade without departing from the scope of the claims.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a surgicalsystem, device, or apparatus that “comprises,” “has,” “includes” or“contains” one or more elements possesses those one or more elements,but is not limited to possessing only those one or more elements.Likewise, an element of a system, device, or apparatus that “comprises,”“has,” “includes” or “contains” one or more features possesses those oneor more features, but is not limited to possessing only those one ormore features.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical”, “horizontal”, “up”, and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, theperson of ordinary skill in the art will readily appreciate that thevarious methods and devices disclosed herein can be used in numeroussurgical procedures and applications including, for example, inconnection with open surgical procedures. As the present DetailedDescription proceeds, those of ordinary skill in the art will furtherappreciate that the various instruments disclosed herein can be insertedinto a body in any way, such as through a natural orifice, through anincision or puncture hole formed in tissue, etc. The working portions orend effector portions of the instruments can be inserted directly into apatient's body or can be inserted through an access device that has aworking channel through which the end effector and elongated shaft of asurgical instrument can be advanced.

Many of the above-listed patent applications disclose various layerswhich are used in connection with a staple cartridge. When staples aredeployed from the staple cartridge, the staples can capture at least onelayer and implant the layer, or layers, against the tissue. Providedbelow is a brief description of a surgical stapling system. The staplecartridges and the layers disclosed herein can be used with thissurgical stapling system and/or any suitable stapling system.

A surgical stapling system can comprise a shaft and an end effectorextending from the shaft. The end effector comprises a first jaw and asecond jaw. The first jaw comprises a staple cartridge. The staplecartridge is insertable into and removable from the first jaw; however,other embodiments are envisioned in which a staple cartridge is notremovable from, or at least readily replaceable from, the first jaw. Thesecond jaw comprises an anvil configured to deform staples ejected fromthe staple cartridge. The second jaw is pivotable relative to the firstjaw about a closure axis; however, other embodiments are envisioned inwhich first jaw is pivotable relative to the second jaw. The surgicalstapling system further comprises an articulation joint configured topermit the end effector to be rotated, or articulated, relative to theshaft. The end effector is rotatable about an articulation axisextending through the articulation joint. Other embodiments areenvisioned which do not include an articulation joint.

The staple cartridge comprises a cartridge body. The cartridge bodyincludes a proximal end, a distal end, and a deck extending between theproximal end and the distal end. In use, the staple cartridge ispositioned on a first side of the tissue to be stapled and the anvil ispositioned on a second side of the tissue. The anvil is moved toward thestaple cartridge to compress and clamp the tissue against the deck.Thereafter, staples removably stored in the cartridge body can bedeployed into the tissue. The cartridge body includes staple cavitiesdefined therein wherein staples are removably stored in the staplecavities. The staple cavities are arranged in six longitudinal rows.Three rows of staple cavities are positioned on a first side of alongitudinal slot and three rows of staple cavities are positioned on asecond side of the longitudinal slot. Other arrangements of staplecavities and staples may be possible.

The staples are supported by staple drivers in the cartridge body. Thedrivers are movable between a first, or unfired position, and a second,or fired, position to eject the staples from the staple cavities. Thedrivers are retained in the cartridge body by a retainer which extendsaround the bottom of the cartridge body and includes resilient membersconfigured to grip the cartridge body and hold the retainer to thecartridge body. The drivers are movable between their unfired positionsand their fired positions by a sled. The sled is movable between aproximal position adjacent the proximal end and a distal positionadjacent the distal end. The sled comprises a plurality of rampedsurfaces configured to slide under the drivers and lift the drivers, andthe staples supported thereon, toward the anvil.

Further to the above, the sled is moved distally by a firing member. Thefiring member is configured to contact the sled and push the sled towardthe distal end. The longitudinal slot defined in the cartridge body isconfigured to receive the firing member. The anvil also includes a slotconfigured to receive the firing member. The firing member furthercomprises a first cam which engages the first jaw and a second cam whichengages the second jaw. As the firing member is advanced distally, thefirst cam and the second cam can control the distance, or tissue gap,between the deck of the staple cartridge and the anvil. The firingmember also comprises a knife configured to incise the tissue capturedintermediate the staple cartridge and the anvil. It is desirable for theknife to be positioned at least partially proximal to the rampedsurfaces such that the staples are ejected ahead of the knife.

An implantable adjunct, or layer, disclosed herein comprises means forallowing a clinician to determine the degree of skew, if any, that theadjunct experiences when implanted against the tissue of a patient by asurgical stapling instrument. The implantable adjunct comprises one ormore reference systems configured to assist a clinician in assessing theposition of the staples in the adjunct once the adjunct has beenimplanted into the subject by the staples. The reference systems arepositioned on and/or in the adjunct to correspond to features of thestapling instrument. Moreover, the one or more reference systems furtherdefine different zones of the adjunct. Once the adjunct is purchased, orcaptured, by the staples, a clinician can easily determine what zone, orzones, of the adjunct the staples have satisfactorily, and/orunsatisfactorily, captured.

An implantable adjunct disclosed herein may comprise different zonesdefined by one or more reference systems. The clinician is able to seethe different zones to more easily distinguish the position of theformed staples relative to the edges of the adjunct, the formed staplerows, and/or the reference systems of the adjunct. In variousembodiments, the one or more reference systems and/or zones are used todetermine if the implantable adjunct experienced lateral and/orlongitudinal skew after being implanted with the surgical instrument bycomparing the position of the formed staples relative to the one or morereference systems and determining what zone, or zones, of the adjunctthat the formed staples purchased the adjunct. Once a clinician can seewhat zones of the adjunct that the staples have captured, the cliniciancan determine the quality of the staple purchase and further decide if,and what, further action may be necessary.

An end effector assembly, or system, 100 is depicted in FIG. 1. The endeffector assembly 100 comprises a first jaw 101, a second jaw 103, andan implantable adjunct 120. The first jaw 101 comprises a staplecartridge 130 and a cartridge channel 150. The staple cartridge 130comprises a cartridge pan 140 which is configured to hold a plurality ofstaple drivers, which support a plurality of staples 132, and a sled inthe staple cartridge 130. The cartridge channel 150 is configured tohouse the staple cartridge 130 and is operably coupled to the endeffector assembly 100. The staple cartridge 130 is readily removablefrom the first jaw 101 and can be replaced with another staplecartridge. Other embodiments are envisioned in which the staplecartridge 130 is not readily removable from the first jaw 101. Thesecond jaw 103 comprises an anvil 110 which comprises a staple formingsurface 113. The staple forming surface 113 comprises a plurality offorming pockets configured to deform the staples 132. The second jaw 103is rotatable relative to the first jaw 101 and, thus, the anvil 110 isrotatable relative to the staple cartridge 130; however, certainembodiments are envisioned in which the staple cartridge 130 isrotatable relative to the anvil 110.

The staple cartridge 130 comprises a cartridge body 139 including acartridge deck 135, a plurality of staple cavities 131 defined in thecartridge body 139 and configured to store the plurality of staples 132and/or any other suitable fastener therein, and a longitudinal slot 137configured to receive a cutting member 160. The cartridge body 139comprises a proximal end portion 139P, a distal end portion 139D, andouter lateral edges 138. The cutting member 160 is configured totraverse the slot 137 from the proximal end portion 139P to the distalend portion 139D to push the sled distally and drive the staples 132toward the staple forming surface 113 at which point the staple formingsurface 113 deforms the staples 132.

The staple cavities 131 and staples 132 stored in the staple cavities131 are arranged in a plurality of longitudinal rows on each side of theslot 137. On one side of the slot 137, the plurality of rows comprisesan inner row of staple cavities 131C positioned adjacent to andlaterally outward with respect to the slot 137, an outer row of staplecavities 131A positioned adjacent to and laterally inward with respectto the outer lateral edge 138 of the staple cartridge 130, and anintermediate row of staple cavities 131B positioned between the outerrow of staple cavities 131A and the inner row of staple cavities 131C.In other words, the inner rows of staple cavities 131C are nearest theslot 137, the outer rows of staple cavities 131A are nearest thecartridge edges, and, on each side of the slot 137, the intermediaterows of staple cavities 131B are intermediate the inner row of staplecavities 131C and the outer row of staple cavities 131A. The staplecavities 131 also comprise proximal staple cavities near the proximalend portion 139P of the cartridge body 139 which define a proximalpurchase datum PPD and distal staple cavities near the distal endportion 139D of the cartridge body 139 which define a distal purchasedatum DPD.

Turning now to FIGS. 2-5, the implantable adjunct 120 comprises outeradjunct edges 122, a tissue-contacting surface 124 facing the stapleforming surface 113 of the anvil 110 when attached to the staplecartridge 130, a deck-contacting surface 121 facing the deck 137, and areference system 123. The reference system 123 is visible at least onthe deck-contacting surface 121 of the implantable adjunct 120. Otherembodiments are envisioned where the implantable adjunct 120 is attachedto the anvil 110, and/or staple forming surface 113, of the surgicalinstrument, and, in this case, the reference system 123 would be visibleon an anvil-contacting surface facing the staple forming surface 113.The adjunct 120 can be releasably retained to the cartridge deck 137 ofthe staple cartridge 130 or the staple forming surface 113 by anysuitable means such as straps, adhesive, pins, a snap-fit connection,and/or VELCRO, for example.

The reference system 123 comprises outer lateral references 125 andinner lateral references 126. The location of the references 125, 126correspond to the staple cavities 131, the outer edges 138 of the staplecartridge 130, and the slot 137 of the staple cartridge 130. The outerlateral references 125 are positioned laterally outward (toward theouter edges 138 of the staple cartridge 130) with respect to the outerrows of staple cavities 131A and laterally inward (toward the slot 137)with respect to the outer edges 138 of the staple cartridge 130. Theinner lateral references 126 are positioned laterally outward (towardthe outer edges 138 of the staple cartridge 130) with respect to theslot 137 and laterally inward (toward the slot 137) with respect to theinner rows of staple cavities 131C.

The inner lateral references 126 and the outer lateral references 125can act as a reference, or target indicator, for the clinician toanalyze after firing the surgical stapling instrument. To aid theclinician in determining the quality of the staple purchase, the innerlateral references 126 and the outer lateral references 125 define afirst zone 127A and a second zone 127B. The first zone 127A comprisesthe area, and/or volume, of the adjunct 120 between the inner lateralreferences 126 and the outer lateral references 125. The second zone127B comprises the area, and/or volume, of the adjunct 120 between theinner lateral references 126 as well as, the area, and/or volume, of theadjunct 120 disposed laterally outward (toward the outer edges 138 ofthe staple cartridge 130) of the outer lateral references 125.

In FIG. 4, a first scenario is illustrated where the implantable adjunct120 and tissue T have been secured by the staples 132. The adjunct 120and the tissue T have been incised at least substantially along theintended cut-line CL. The adjunct 120 and the tissue T have been securedby multiple rows of staples comprising outer rows of staples 132A,intermediate rows of staples 132B, and inner rows of staples 132C whichcorrespond to the rows of staple cavities 131A, 131B, 131C,respectively. This first scenario comprises a situation where all of thestaples 132 have captured the adjunct 120 in the first zone 127A. Insuch a scenario, a clinician can visually identify that all of thestaples 132 have captured the adjunct 120 in the first zone 127A.Moreover, the reference system 123 also permits the clinician to easilydetermine that none of the staples 132 captured the adjunct 120 in thesecond zone 127B. Based on these observations, the clinician can beassured that none of the staples 132 missed, or failed to capture, theadjunct 120. In addition, the clinician can be assured that none of thestaples 132 captured the adjunct 120 in an area which may be too closeto the edge 122 of the adjunct 120, for example, or in an area which maynot provide an optimal securement of the tissue T.

In FIG. 5, a second scenario is illustrated where the adjunct 120 wasnot incised along the intended cut-line CL of the adjunct 120. Rather,in this second scenario, the adjunct 120 was skewed laterally before itwas implanted and was incised along an actual cut-line CL′. Unlike thefirst scenario shown in FIG. 4, the adjunct 120 was only captured bysome of the staples 132. In this second scenario, some of the staples132 captured the adjunct in the first zone 127A, some of the staples 132captured the adjunct 120 in the second zone 127B, some of the staples132 captured the adjunct 120 in both the first zone 127A and the secondzone 127B, and some of the staples 132 did not capture the adjunct 120at all. In such a situation, a clinician can visibly identify, using thereference system 123, that some of the staples 132 have purchased, orcaptured, the adjunct 120 in the second zone 127B and that some of thestaples 132 have missed the adjunct 120 entirely. Being able to easilyidentify the precise location of the formed staples 132 relative to theedges 122 of the adjunct 120 allows the clinician to determine that thequality of purchase of the staples 132 in the second zone 127B may beless than that of the quality of purchase of the staples 132 in thefirst zone 127A. This information, easily identifiable using the zones127A, 127B and the references 125, 126, helps the clinician determinewhether further action is necessary.

The reference system 123 in FIG. 5 visually amplifies the position ofthe formed staples 132 relative to the references 125, 126 of thereference system 123. The references 125, 126 are at least substantiallyparallel to the formed staple rows 132A, 132B, 132C. In certaininstances, a clinician can also determine whether the zones 127A, 127Bmay be misaligned with the staple rows 132A, 132B, 132C when thereferences 125, 126 are not at least substantially parallel to thestaple rows 132A, 132B, 132C since the staples are formed in at leastsubstantially straight lines in this example.

In various embodiments, the second zone 127B discussed above comprisesan outer zone and a cut-line zone. The outer zone comprises the area ofthe second zone 127B positioned laterally outward with respect to theouter lateral references 125. The cut-line zone comprises the area ofthe second zone 127B that the cutting member 160 of the surgicalinstrument is intended to incise. In this example, the cut-line zonecomprises the area of the second zone 127B found between the innerlateral references 126. In some instances, a clinician may view thestaples 132 that capture the adjunct 120 in the cut-line zone asrequiring a closer inspection than the staples 132 that capture theadjunct 120 in the outer zone. This is due to the fact that the staples132 near the cut-line zone are in close proximity to the newly incisedtissue. The clinician may see the staples 132 in the cut-line zone as ahigher risk in terms of tissue ligation, or joining, because of thenewly incised tissue in this area. Moreover, it may be more important tohave a higher quality staple purchase near the intended cut-line CL, orin the cut-line zone altogether, than the outer zone.

In addition, the form of the staples may be affected if the adjunct 120becomes skewed before it is stapled. For instance, a desired staple formmay be a B-form, a bow-tie form, or a box form, for example, and, if thestaples only catch an edge of the adjunct 120 and/or miss the adjunct120 entirely, the staples may not form in the desired manner. Thesurgeon can use the reference system to look for staples that may haveassumed a different staple form than what was intended.

In various embodiments, the reference systems disclosed herein maycomprise different colors, for example. Different color zones aid theclinician in more easily determining where the cutting member 160, orknife, of the surgical instrument incised the implantable adjunct 120 ina desired location. For example, the cut-line zone of the second zone127B, discussed above, may comprise a first color such as yellow and thefirst zone 127A may comprise a second color such as blue. The colors maybe any suitable colors. In the event that the cutting member 160 incisesthe first zone 127A of the adjunct 120, for example, the cutting member160 at least partially transects the yellow and the blue zones and aclinician would be able to visually distinguish, using the contrast ofcolors, where the cutting member 160 incised the adjunct 120. Moreover,this reference system, along with the other reference systems disclosedherein, can show if the adjunct on the staple cartridge was skewed withrespect to the staple lines of the staple cartridge when the staplecartridge was inserted into and/or manipulated within the surgical site.Many of such reference systems will only be visible after the stapleshave been fired and the end effector has been unclamped from the tissue.At such a point, a surgeon can utilize the reference systems to see ifthe appropriate zones in the adjunct are, or are not, aligned with thestaple lines and determine the impact, if any, when the adjunct has beenshifted relative to the staple lines and if any further correctiveactions are required.

FIG. 6 depicts another reference system 223 employed with an implantableadjunct 220. The reference system 223 is similar to the reference system123 in many respects, however, the reference system 223, visible atleast on a deck-contacting surface 221, comprises only one inner lateralreference 226. The inner lateral reference 226 is aligned with, or atleast substantially aligned with, the intended cut-line CL. Thereference system 223 further comprises outer lateral references 225arranged similarly to that of the outer lateral references 125 discussedabove. The reference system 223 defines a first zone 227A and a secondzone 227B. The first zone 227A comprises the area, and/or volume, of theadjunct 220 located between the outer lateral references 225 and isintended to be split, divided, and/or bifurcated along the intendedcut-line CL by the cutting member 160, for example. The second zone 227Bcomprises the remaining area, and/or volume, of the adjunct 220 locatedlaterally outward (toward the edges 122) of the outer lateral references225. The inner lateral reference 226 is configured to be incised, and,if the adjunct 220 does not shift relative to the cartridge 130 duringthe stapling procedure, the inner lateral reference 226 will be incisedcompletely. In some instances, a clinician may not be able to see theinner lateral reference 226 if no lateral skew has occurred because theinner lateral reference 226 was entirely incised. Embodiments areenvisioned where the first zone 227A comprises different colors; onecolor on one side of the slot 137 and one color on the other side ofslot 137. In at least one embodiment, the reference 226 divides the twocolors. This allows the clinician to more accurately determine where thecutting member 160 traversed the implantable adjunct 220. For example,if the cutting member 160 incises the implantable adjunct 220 at alocation other than the intended cut-line CL, the clinician will be ableto see the first color and the second color on one side of the actualcut-line CL′. The clinician will then determine that the cutting member160 did not incise the adjunct 220 along the intended cut-line CL.

Another alternative embodiment includes a reference system comprisinglateral references, similar to those discussed above, which arepositioned between and at least substantially parallel to each staplerow. For example, a first lateral reference is positioned such that thefirst lateral reference corresponds to a position between the outer rowof staples and the intermediate row of staples while a second lateralreference is positioned such that the second lateral referencecorresponds to a position between the intermediate row of staples andthe inner row of staples. If the staples purchase the adjunct 220 suchthat one or more formed staples cross, traverse, and/or capture, thefirst lateral reference and/or the second lateral reference, theclinician could easily determine that the adjunct 220 skewed laterallybefore it was implanted.

Referring now to FIGS. 7-11C, an adjunct 320 comprises a proximal edge328P, a distal edge 328D, a deck-contacting surface 321, and a referencesystem 323. The reference system 323 is configured to allow a clinicianto determine longitudinal skew of the adjunct 320 with respect to thestaple cartridge 130 and/or staples 132, for example. This referencesystem 323 may be employed with other reference systems disclosedherein; however, for clarity, the reference system 323 is shownindependently.

The reference system 323 is visible at least on the deck-contactingsurface 321 of the adjunct 120. The reference system 323 is configuredto display, or visually amplify, any longitudinal displacement of theadjunct 320 when implanted into a subject. A clinician can use thereference system 323 in a similar fashion to that of the other referencesystems disclosed herein. The reference system 323 comprises a proximalreference 325 and a distal reference 326. The references 325, 326 areperpendicular, or at least substantially perpendicular, to the intendedcut-line CL. The proximal reference 325 is disposed near the proximaledge 328P of the adjunct 320 and the distal reference 326 is disposednear the distal edge 328D of the adjunct 320. Embodiments are envisionedwhere the reference system 323 comprises one or more intermediatelongitudinal references positioned between the proximal reference 325and the distal reference 326. Other embodiments are envisioned where thereference system 323 comprises only one of the proximal reference 325and the distal reference 326.

The proximal reference 325 and the distal reference 326 can act as areference, or target indicator, for the clinician after firing thesurgical stapling instrument. The proximal reference 325 is locatedproximal the proximal purchase datum PPD (discussed above). The distalreference 326 is located distal the distal purchase datum DPD (discussedabove). The references 325, 326 define a proximal zone 327A, anintermediate zone 327B, and a distal zone 327C. The proximal zone 327Acomprises the area, and/or volume, of the adjunct 320 disposed proximalthe proximal reference 325. The intermediate zone 327B comprises thearea, and/or volume, of the adjunct 320 disposed between the proximalreference 325 and the distal reference 326. The distal zone 327Ccomprises the area, and/or volume, of the adjunct 320 disposed distal ofthe distal reference 326. The proximal zone 327A comprises theproximal-most edge 128P of the adjunct 320. The distal zone 327Ccomprises the distal-most edge 128D of the adjunct 320. The proximalpurchase datum PPD and the distal purchase datum DPD are located atleast substantially in the intermediate zone 327B. In other words, theproximal purchase datum PPD is located proximal to the distal reference326 and the distal purchase datum DPD is located distal to the proximalreference 325. Other embodiments are envisioned where the proximalpurchase datum PPD is aligned with the proximal reference 325 and thedistal purchase datum DPD is aligned with the distal reference 326.

In the scenario illustrated in FIG. 9, the staples 132 have captured theimplantable adjunct 320 in the manner shown. The adjunct 320 was incisedat least substantially along the intended cut-line CL. This scenariocomprises a situation where all of the staples 132 captured the adjunct320 in the intermediate zone 327B. Since none of the staples 132captured the adjunct 320 and the tissue T in the proximal zone 327A orthe distal zone 327C, the clinician can verify that the datum PPD, DPDremained between the references 325, 326. The clinician may then decideto reload the surgical instrument and proceed with the next part of theprocedure.

In another scenario illustrated in FIG. 10, the staples 132 havecaptured the adjunct 320 in the manner shown. The adjunct 320 wasincised at least substantially along the intended cut-line CL. In thisscenario, some of the staples 132 purchased the adjunct 320 in theintermediate zone 327B and some of the staples 132 purchased the adjunct320 in both the intermediate zone 327B and the distal zone 327C. In suchan instance, a clinician can visibly identify that some of the staples132 have purchased, or captured, the adjunct in the distal zone 327C andthat the distal purchase datum DPD of the staples ended up distal to thedistal reference 326 which can prompt the clinician to evaluate thestaples 132, especially the staples 132 in the distal zone 327C. Thisinformation, easily identifiable using the reference system 323, canhelp the clinician determine whether further action is necessary.

When some of the staples 132 purchase the adjunct 320 in the distal zone327C, a clinician may want to take this into consideration when aligningthe surgical stapling instrument to perform a next step of the staplingoperation. The distal reference 326 can act as an end-zone which isconfigured to help the clinician identify the end-of-cut EOC relative tothe position of the implanted adjunct 320 and/or the staples 132. Theend-of-cut EOC can be defined by the furthest point that the cuttingmember 160 incised the tissue T and the adjunct 320. Referring to FIGS.11-11C, different scenarios are depicted where the implantable adjunct320 employing the reference system 323 skews distally (FIG. 11A), skewsproximally (FIG. 11B), and does not skew at all (FIG. 11C). Shown inFIG. 11, the distal reference 326 is at aligned with, and correspondsto, the end-of-cut EOC. FIG. 11A illustrates a scenario where the distalreference 326 has not been traversed by the cutting member 160. In thisinstance, the clinician may assume that the implanted adjunct 320 skeweddistally, and/or stretched. FIG. 11B illustrates another scenario wherethe distal reference 326 has been traversed by the cutting member 160.In this instance, the clinician may assume that the implanted adjunct320 skewed proximally, and/or shrunk. FIG. 11C illustrates a thirdscenario where the distal reference 326 is aligned, or is substantiallyaligned, with the end-of-cut. In this instance, the clinician may assumethat the adjunct 320 did not skew longitudinally and that the adjunct320 was implanted on target.

FIG. 12 depicts an implantable adjunct 400 comprising a woven material421, a reference system 423 integrally woven into the adjunct 400, and adeck-contacting surface 424. The reference system 423, visible at leaston the deck-contacting surface 424, comprises inner lateral references426 and outer lateral references 425. The references 425, 426 are sewninto the woven material 421. Other embodiments are envisioned where thereferences 425, 426 are sewn into a non-woven material. Each reference425, 426 may comprise a thread having a color which is different thanthe underlying material 421 to help the clinician readily identify thereferences 425, 426. The inner lateral references 426 may comprise afirst color and the outer lateral references 425 may comprise a secondcolor, wherein the first color is different than the second color. Thethreads used for the references 425, 426 may be dyed a specific color,or colors, before being sewn into the adjunct 400, for example. Thethreads comprising the references 425, 426 may be sewn into the material421 and may be visible on both sides of the adjunct 420. In such anembodiment, the clinician could use the references 425, 426 before andafter stapling the tissue.

FIG. 13 depicts an implantable adjunct 500 comprising a woven referencesystem 523 and a deck-contacting surface 524. The woven reference system523 comprises outer lateral references 525A, 525B and an inner lateralreference 526. The inner lateral reference 526 is similar to that of theinner lateral reference 226 discussed above. In the scenario depicted inFIG. 13, the adjunct 500 moved laterally during the surgical staplingprocedure. Since the inner lateral reference 526 corresponds to theintended cut-line CL, the clinician can easily determine lateral skewwhen the clinician sees some of the inner lateral reference 526 on oneside of the actual cut-line CL′ and some of the inner lateral reference526 on another side of the actual cut-line CL′.

Similar to the zones discussed above, the implantable adjunct 500comprises different colors to visually amplify the zones of the adjunct.For example, the adjunct 500 comprises colors 530, 540, 550. The color530 at least substantially covers the area of the deck-contactingsurface 524 found laterally outward with respect to the outer references525A, 525B. The color 540 at least substantially covers the area of thetissue-contacting surface 524 found between the outer lateral reference525A and the inner lateral reference 526. The color 550 at leastsubstantially covers the area of the tissue-contacting surface foundbetween the outer lateral reference 525B and the inner lateral reference526. Such colors allow the clinician to more accurately determine wherethe staples 132 captured the adjunct 520 and/or where the cutting member160 traversed the implantable adjunct 520. For example, after firing thesurgical stapling instrument and removing the instrument from the siteto see the adjunct 500, the clinician may see the color 540 on one sideof the actual cut-line and the color 550 on the other side of the actualcut-line. In this case, the clinician can determine that the cuttingmember 160 at least substantially cut the adjunct through the intendedcut-line CL. If the clinician sees both colors 540, 550 on one side ofthe actual cut-line CL′, as illustrated in FIG. 13, the clinician candetermine that the adjunct laterally skewed with respect to the staplecartridge 130.

An implantable adjunct 620 implanted into tissue T is depicted in FIG.14. The implantable adjunct 620 comprises a reference system 623, outeredges 622, and an intended cut-line CL. The reference system 623comprises staple row references 625 which are aligned with, or at leastsubstantially aligned with, the rows of staple cavities 131A, 131B,131C. The staple row references 625 correspond to the rows of staplecavities 131A, 131B, 131C such that a satisfactory implantation of theadjunct 620 comprises a situation where the staples 132 capture theadjunct 620 along the staple row references 625. A potentiallyunsatisfactory implantation of the adjunct 620, illustrated in FIG. 14,may comprise a situation where the row references 625 become misalignedwith the staples 132. The reference system 623 allows a clinician toidentify the misalignment of the formed staple rows 132A, 132B, 132Cwith respect to the staple row references 625 and determine whetherfurther action is necessary. In at least one embodiment, for example,the reference system 623 comprises six longitudinal row references 625which are aligned, or alignable, with six longitudinal rows of staplescavities and the staples stored therein. The longitudinal references 625are straight to match the straight underlying longitudinal rows ofstaple cavities/staples; however, embodiments are envisioned in whichthe longitudinal references are curved to match curved underlyinglongitudinal rows of staple cavities/staples.

In various embodiments, the reference systems are directly dyed intoand/or onto the implantable adjunct. For woven adjuncts, the referencesmay be woven directly into the adjunct. Such references can comprise adyed strand, for example, comprising the same or different material thanthe adjunct itself. VICRYL strands may be incorporated into an adjunctduring a compression molding process. The VICRYL strands can bespecifically positioned in the mold to correspond to the referencesdiscussed above. For adjuncts manufactured using an extrusion process,dye may be added to the extrusion process to directly dye the referencesonto the adjunct. The outer edges of an adjunct may also be dyed toprovide further reference to a clinician in the event that the adjunctis not easily distinguishable from the tissue. For example, atranslucent adjunct may occlude visibility through the adjunct whenimplanted into a subject. Dye, and/or paint, for example, can be appliedto one or both sides of the adjunct to provide the references disclosedherein.

In various embodiments, a reference system may comprise pattern schemesto help a clinician further identify adjunct activity. One example of apattern scheme may comprise reference circles, for example. The circlescan be used to visually identify adjunct stretch. The circles wouldstretch to ovals, or shrink to ovals, which would be easily visible, ordiscernible, to a clinician. Other examples of pattern schemes include azig-zag pattern that weaves around the staples or shapes that correspondto each of the staple's position. Other adjunct activity may comprise,for example, tearing, slipping, bunching, lifting, crumpling, folding,expansion, and/or contraction.

Methods for distinguishing the staples from the implantable adjunct mayinvolve color-changing and/or material activated dye. The adjunct may bemanufactured to include color-changing dye which can be activated by thestaples, fluids in the subject, and/or features of the surgicalinstrument such as the cartridge deck, for example. For instance, anadjunct may comprise a first color configured to change to a secondcolor upon contact with the material of the staples. This method mayhighlight, or emphasize, for example, the presence of the staples as,and/or after, the staples purchase the adjunct.

In order to amplify the visibility of the staples in an embodimentcomprising a transparent adjunct, the adjunct may comprise an innerbladder and an outer body surrounding the inner bladder. The innerbladder may comprise a first color dye configured to be released uponthe puncturing of the inner bladder by the staples. In at least oneinstance, the dye is configured to emerge from the adjunct and/or ontothe staple legs to amplify the location of the staples with respect tothe adjunct.

Other embodiments are envisioned where the anvil of the surgicalinstrument comprises features configured to stamp the references on thetissue-contacting surface of the adjunct.

EXAMPLES Example 1

A staple cartridge system for use with a surgical stapling instrument,the staple cartridge system comprising a cartridge body including alongitudinal slot configured to receive a cutting member, a deck, and aplurality of staple cavities comprising an outer row of staple cavitiesand an inner row of staple cavities positioned adjacent the longitudinalslot. The staple cartridge system further comprises a plurality ofstaples removably stored within the staple cavities, wherein the staplesare configured to be ejected from the staple cavities from an unfiredposition to a fired position, and an implantable adjunct positionedadjacent the deck, wherein the implantable adjunct is configured to beimplanted into a subject when the staples are ejected from the staplecavities into the fired position, wherein the implantable adjunctcomprises a reference system that defines a first zone and a secondzone, and wherein the reference system is configured to assist aclinician in determining the position of the staples relative to thefirst zone and the second zone when the staples are in the firedposition.

Example 2

The staple cartridge system of Example 1, wherein the reference systemcomprises a longitudinal reference positioned such that the cliniciancan determine the amount of longitudinal skew of the implantable adjunctby comparing the staples to the longitudinal reference when the staplesare in the fired position.

Example 3

The staple cartridge system of Examples 1 or 2, wherein the plurality ofstaple cavities further comprises at least one distal-most cavity and atleast one proximal-most cavity, wherein the at least one distalmost-cavity defines a distal purchase datum and the at least oneproximal-most cavity defines a proximal purchase datum, and wherein thedistal purchase datum and the proximal purchase datum are positioned inthe first zone when the staples are in the unfired position.

Example 4

The staple cartridge system of Examples 1, 2, or 3, wherein thereference system comprises a lateral reference positioned such that aclinician can determine the amount of lateral skew of the implantableadjunct by comparing the staples to the reference when the staples arein the fired position.

Example 5

The staple cartridge system of Example 4, wherein the cartridge bodycomprises an outer edge, wherein the outer row of staple cavities ispositioned adjacent the outer edge, and wherein the lateral referencecomprises a first reference positioned between the outer edge and theouter row of staple cavities.

Example 6

The staple cartridge system of Example 5, wherein the reference systemfurther comprises a second reference positioned between the inner row ofstaple cavities and the slot.

Example 7

The staple cartridge system of Examples 1, 2, 3, 4, 5, or 6, wherein thereference system comprises dye applied on the implantable adjunct.

Example 8

The staple cartridge system of Examples 1, 2, 3, 4, 5, 6, or 7, whereinthe implantable adjunct comprises a woven material.

Example 9

The staple cartridge system of Example 8, wherein the referencecomprises a colored strand woven into the woven material.

Example 10

The staple cartridge system of Examples 1, 2, 3, 4, 5, 6, 7, 8, or 9,wherein the implantable adjunct comprises a non-woven material.

Example 11

The staple cartridge system of Examples 1, 2, 3, 4, 5, 6, 7, 8, 9, or10, wherein the first zone comprises a first color and a second color,wherein the first color and the second color are divided by an intendedcut-line, and wherein the cutting member is configured to incise theimplantable adjunct along the intended cut-line.

Example 12

The staple cartridge system of Examples 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,or 11, wherein the reference system comprises two inner lateralreferences, wherein the area between the two inner lateral referencesdefines the second zone, and wherein the cutting member is configured toincise the implantable adjunct in the second zone.

Example 13

A staple cartridge system for use with a surgical stapling instrument,the staple cartridge system comprising a cartridge body including alongitudinal slot configured to receive a cutting member, a deck, and aplurality of staple cavities arranged in a plurality of longitudinalrows. The staple cartridge system further comprises a plurality ofstaples removably stored within the staple cavities, wherein the staplesare configured to be ejected from the staple cavities into a firedposition, and an implantable adjunct positioned above the deck, whereinthe implantable adjunct is configured to be implanted into a subjectwhen the staples are ejected from the staple cavities into the firedposition, and wherein the implantable adjunct comprises a reference fordetermining the alignment of the plurality of staples relative to theimplantable adjunct once the staples are in the fired position.

Example 14

The staple cartridge system of Example 13, wherein the plurality ofstaple cavities comprises an outer row of staple cavities and an innerrow of staple cavities, wherein the inner row of staple cavities isadjacent the longitudinal slot, and wherein the reference systemcomprises a first reference corresponding to the inner row of staplecavities and a second reference corresponding to the outer row of staplecavities.

Example 15

The staple cartridge system of Examples 13 or 14, wherein theimplantable adjunct comprises a woven material.

Example 16

The staple cartridge system of Examples 13, 14, or 15, wherein theimplantable adjunct comprises a non-woven material.

Example 17

A surgical end effector system comprising a cutting member, a first jaw,a second jaw, wherein the first jaw is moveable relative to the secondjaw, an anvil, and a staple cartridge including an outer edge portion, aplurality of staple cavities arranged in a plurality of rows, aplurality of staples configured to be ejected from the staple cavities,wherein the staples are arranged in an inner row of staples and an outerrow of staples, and a slot, wherein the inner row of staples ispositioned laterally outward with respect to the slot, and wherein theouter row of staples is positioned laterally outward with respect to theinner row of staples and laterally inward with respect to the outeredge. The end effector comprises an implantable adjunct, comprising areference system defining a first zone and a second zone, wherein thefirst zone corresponds to the inner row of staples and the outer row ofstaples such that before the staples are ejected from the staplecavities, the first zone is above the inner row of the staples and theouter row of the staples, and wherein the second zone corresponds to theslot and the outer edge portion such that, before the staples areejected from the staple cavities, the second zone is above the outeredge portion and the slot.

Example 18

The surgical end effector system of Example 17, wherein the first zonecomprises a first color and the second zone comprises a second colorwhich is different than the first color.

Example 19

The surgical end effector system of Examples 17 or 18, wherein theimplantable layer comprises a non-woven material.

Example 20

The surgical end effector system of Examples 17, 18, or 19, wherein theimplantable layer comprises a woven material.

Various embodiments are disclosed including adjuncts attached to and/orpositioned on a staple cartridge. It should be understood that suchteachings are applicable to embodiments in which an adjunct is attachedto and/or positioned on an anvil of a surgical instrument. In fact,embodiments are envisioned in which a first adjunct is attached toand/or positioned on a cartridge and a second adjunct is attached toand/or positioned on an anvil.

The entire disclosures of:

U.S. Pat. No. 5,403,312, entitled ELECTROSURGICAL HEMOSTATIC DEVICE,which issued on Apr. 4, 1995;

U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS, which issued on Feb. 21,2006;

U.S. Pat. No. 7,422,139, entitled MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK, which issued onSep. 9, 2008;

U.S. Pat. No. 7,464,849, entitled ELECTRO-MECHANICAL SURGICAL INSTRUMENTWITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS, which issued on Dec.16, 2008;

U.S. Pat. No. 7,670,334, entitled SURGICAL INSTRUMENT HAVING ANARTICULATING END EFFECTOR, which issued on Mar. 2, 2010;

U.S. Pat. No. 7,753,245, entitled SURGICAL STAPLING INSTRUMENTS, whichissued on Jul. 13, 2010;

U.S. Pat. No. 8,393,514, entitled SELECTIVELY ORIENTABLE IMPLANTABLEFASTENER CARTRIDGE, which issued on Mar. 12, 2013;

U.S. patent application Ser. No. 11/343,803, entitled SURGICALINSTRUMENT HAVING RECORDING CAPABILITIES; now U.S. Pat. No. 7,845,537;

U.S. patent application Ser. No. 12/031,573, entitled SURGICAL CUTTINGAND FASTENING INSTRUMENT HAVING RF ELECTRODES, filed Feb. 14, 2008;

U.S. patent application Ser. No. 12/031,873, entitled END EFFECTORS FORA SURGICAL CUTTING AND STAPLING INSTRUMENT, filed Feb. 15, 2008, nowU.S. Pat. No. 7,980,443;

U.S. patent application Ser. No. 12/235,782, entitled MOTOR-DRIVENSURGICAL CUTTING INSTRUMENT, now U.S. Pat. No. 8,210,411;

U.S. patent application Ser. No. 12/249,117, entitled POWERED SURGICALCUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM,now U.S. Pat. No. 8,608,045;

U.S. patent application Ser. No. 12/647,100, entitled MOTOR-DRIVENSURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROLASSEMBLY, filed Dec. 24, 2009; now U.S. Pat. No. 8,220,688;

U.S. patent application Ser. No. 12/893,461, entitled STAPLE CARTRIDGE,filed Sep. 29, 2012, now U.S. Pat. No. 8,733,613;

U.S. patent application Ser. No. 13/036,647, entitled SURGICAL STAPLINGINSTRUMENT, filed Feb. 28, 2011, now U.S. Pat. No. 8,561,870;

U.S. patent application Ser. No. 13/118,241, entitled SURGICAL STAPLINGINSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S. Pat.No. 9,072,535;

U.S. patent application Ser. No. 13/524,049, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, filed on Jun. 15, 2012;now U.S. Pat. No. 9,101,358;

U.S. patent application Ser. No. 13/800,025, entitled STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, now U.S. PatentApplication Publication No. 2014/0263551;

U.S. patent application Ser. No. 13/800,067, entitled STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, now U.S. PatentApplication Publication No. 2014/0263552;

U.S. Patent Application Publication No. 2007/0175955, entitled SURGICALCUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM,filed Jan. 31, 2006; and

U.S. Patent Application Publication No. 2010/0264194, entitled SURGICALSTAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR, filed Apr. 22,2010, now U.S. Pat. No. 8,308,040, are hereby incorporated by referenceherein.

Although the various embodiments of the devices have been describedherein in connection with certain disclosed embodiments, manymodifications and variations to those embodiments may be implemented.Also, where materials are disclosed for certain components, othermaterials may be used. Furthermore, according to various embodiments, asingle component may be replaced by multiple components, and multiplecomponents may be replaced by a single component, to perform a givenfunction or functions. The foregoing description and following claimsare intended to cover all such modification and variations.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

By way of example only, aspects described herein may be processed beforesurgery. First, a new or used instrument may be obtained and whennecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device also may be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, plasma peroxide, or steam.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A staple cartridge system for use with a surgicalstapling instrument, said staple cartridge system comprising: acartridge body, comprising: a longitudinal slot configured to receive acutting member; a deck; and a plurality of staple cavities, comprising:an outer row of staple cavities; and an inner row of staple cavitiespositioned adjacent said longitudinal slot; and a plurality of staplesremovably stored within said staple cavities, wherein said staples areconfigured to be ejected from said staple cavities from an unfiredposition to a fired position; and an implantable adjunct positionedadjacent said deck, wherein said implantable adjunct is configured to beimplanted into a subject when said staples are ejected from said staplecavities into said fired position, wherein said implantable adjunctcomprises a reference system that defines a first zone and a secondzone, and wherein said reference system is configured to assist aclinician in determining the position of said staples relative to saidfirst zone and said second zone when said staples are in said firedposition.
 2. The staple cartridge system of claim 1, wherein saidreference system comprises a longitudinal reference positioned such thatthe clinician can determine the amount of longitudinal skew of saidimplantable adjunct by comparing said staples to said longitudinalreference when said staples are in said fired position.
 3. The staplecartridge system of claim 2, wherein said plurality of staple cavitiesfurther comprises at least one distal-most cavity and at least oneproximal-most cavity, wherein said at least one distal most-cavitydefines a distal purchase datum and said at least one proximal-mostcavity defines a proximal purchase datum, and wherein said distalpurchase datum and said proximal purchase datum are positioned in saidfirst zone when said staples are in said unfired position.
 4. The staplecartridge system of claim 1, wherein said reference system comprises alateral reference positioned such that a clinician can determine theamount of lateral skew of said implantable adjunct by comparing saidstaples to said reference when said staples are in said fired position.5. The staple cartridge system of claim 4, wherein said cartridge bodycomprises an outer edge, wherein said outer row of staple cavities ispositioned adjacent said outer edge, and wherein said lateral referencecomprises a first reference positioned between said outer edge and saidouter row of staple cavities.
 6. The staple cartridge system of claim 5,wherein said reference system further comprises a second referencepositioned between said inner row of staple cavities and said slot. 7.The staple cartridge system of claim 1, wherein said reference systemcomprises dye applied on said implantable adjunct.
 8. The staplecartridge system of claim 1, wherein said implantable adjunct comprisesa woven material.
 9. The staple cartridge system of claim 8, whereinsaid reference comprises a colored strand woven into said wovenmaterial.
 10. The staple cartridge system of claim 1, wherein saidimplantable adjunct comprises a non-woven material.
 11. The staplecartridge system of claim 1, wherein said first zone comprises a firstcolor and a second color, wherein said first color and said second colorare divided by an intended cut-line, and wherein said cutting member isconfigured to incise said implantable adjunct along the intendedcut-line.
 12. The staple cartridge system of claim 1, wherein saidreference system comprises two inner lateral references, wherein thearea between the two inner lateral references defines said second zone,and wherein said cutting member is configured to incise said implantableadjunct in said second zone.
 13. A staple cartridge system for use witha surgical stapling instrument, said staple cartridge system comprising:a cartridge body, comprising: a longitudinal slot configured to receivea cutting member; a deck; and a plurality of staple cavities arranged ina plurality of longitudinal rows; a plurality of staples removablystored within said staple cavities, wherein said staples are configuredto be ejected from said staple cavities into a fired position; and animplantable adjunct positioned above said deck, wherein said implantableadjunct is configured to be implanted into a subject when said staplesare ejected from said staple cavities into said fired position, andwherein said implantable adjunct comprises a reference for determiningthe alignment of said plurality of staples relative to said implantableadjunct once said staples are in said fired position.
 14. The staplecartridge system of claim 13, wherein said plurality of staple cavitiescomprises an outer row of staple cavities and an inner row of staplecavities, wherein said inner row of staple cavities is adjacent saidlongitudinal slot, and wherein said reference system comprises a firstreference corresponding to said inner row of staple cavities and asecond reference corresponding to said outer row of staple cavities. 15.The staple cartridge system of claim 13, wherein said implantableadjunct comprises a woven material.
 16. The staple cartridge system ofclaim 13, wherein said implantable adjunct comprises a non-wovenmaterial.
 17. A surgical end effector system, comprising: a cuttingmember; a first jaw; a second jaw, wherein said first jaw is moveablerelative to said second jaw; an anvil; a staple cartridge, comprising:an outer edge portion; a plurality of staple cavities arranged in aplurality of rows; a plurality of staples configured to be ejected fromsaid staple cavities, wherein said staples are arranged in an inner rowof staples and an outer row of staples; and a slot, wherein said innerrow of staples is positioned laterally outward with respect to saidslot, and wherein said outer row of staples is positioned laterallyoutward with respect to said inner row of staples and laterally inwardwith respect to said outer edge; an implantable adjunct, comprising areference system defining a first zone and a second zone, wherein saidfirst zone corresponds to said inner row of staples and said outer rowof staples such that before said staples are ejected from said staplecavities, said first zone is above said inner row of said staples andsaid outer row of said staples; and wherein said second zone correspondsto said slot and said outer edge portion such that, before said staplesare ejected from said staple cavities, said second zone is above saidouter edge portion and said slot.
 18. The surgical end effector systemof claim 17, wherein said first zone comprises a first color and saidsecond zone comprises a second color which is different than said firstcolor.
 19. The surgical end effector system of claim 17, wherein saidimplantable layer comprises a non-woven material.
 20. The surgical endeffector system of claim 17, wherein said implantable layer comprises awoven material.